HemoSense INRatio2 User Manual

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INRatio2 Prothrombin Time (PT) Monitoring System

Selbsttest-Benutzerhandbuch

INRatio 2 Prothrombinzeit (PT) Überwachungssystem

Guide de l'utilisateur pour l'autotest

Système de mesure du taux de prothrombine (TP) INRatio 2

Guida Utente per l'autoverifica

Sistema di Monitoraggio del Tempo di Protrombina (PT) INRatio 2

Guía de Usuario para el Autoanálisis

Sistema de Monitorización INRatio 2 del Tiempo de Protrombina (TP)

Zelftest-gebruikershandleiding

INRatio2-systeem voor meting van de protrombinetijd (PT)

Brugervejledning til selvtestning

INRatio 2-systemet til monitorering af protrombintid (PT)

Itsetestauksen käyttöohje

INRatio 2 protrombiiniajan (PT) seurantajärjestelmä

Brukerveiledning ved egentesting

INRatio 2 protrombintid (PT)-overvåkningssystem

Användarhandbok för självanalys

Övervakningssystemet INRatio 2 Prothrombin Time (PT)

Guia de Auto-teste para o Utilizador

Sistema de monitorização do tempo de protrombina (TP) INRatio 2

Self Test User Guide

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Summary of Contents for HemoSense INRatio2

Page 1 Sistema di Monitoraggio del Tempo di Protrombina (PT) INRatio 2 Guía de Usuario para el Autoanálisis Sistema de Monitorización INRatio 2 del Tiempo de Protrombina (TP) Zelftest-gebruikershandleiding INRatio2-systeem voor meting van de protrombinetijd (PT) Brugervejledning til selvtestning INRatio 2-systemet til monitorering af protrombintid (PT) Itsetestauksen käyttöohje INRatio 2 protrombiiniajan (PT) seurantajärjestelmä...
Page 2: Table Of Contents
Self Test User Guide Welcome Congratulations on your purchase of the INRatio2 PT Monitoring System from HemoSense. ™ This guide will provide you with useful information on how to perform PT testing with the INRatio2. Table of Contents page Introduction 1.
Page 3: Introduction
INRatio Test Strips and the Lancet device. Take special note of CAUTIONS throughout this User Guide. You must complete proper training on the INRatio2 PT Monitoring system and practice the test with a health care provider before you begin using the system. Intended Use The INRatio2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood.
Page 4: Contacting Hemosense
Contact HemoSense Customer Service if you have questions about your system kit contents. Customer Service 1-877-436-6444 (toll free) or 1-408-719-1393 Customer Service available 7am – 5pm (PST), Monday – Friday To re-order supplies, contact the distributor who provided you with the INRatio2 system kit. Product Part Number Description...
Page 5: The Inratio2 Pt Monitor
Contact HemoSense Technical Support if you have questions about using your system correctly or if you are having problems with the monitor or strips. Technical Support 1-877-436-6444 (toll free) or 1-408-719-1393 Technical support available 24 hours/day, 7 days/week CAUTION: Contact your health care provider if you have questions about your test results and any actions you should take.
Page 6: Precautions And Limitations
Power Supply Jack Sample Well 5. Precautions and Limitations Certain conditions limit the effectiveness of the INRatio2 PT Monitoring system to work properly and provide accurate results. Take note of these limitations and precautions. Care of your INRatio2 PT monitor • DO NOT allow any liquid to spill on the monitor.
Page 7: Turning The Monitor On And Off
6. Turning the Monitor ON and OFF Follow these steps to turn the monitor ON or OFF. NOTE: The INRatio2 PT Monitor comes with batteries but you must install them before the monitor will turn ON. See Installing/Replacing Monitor Batteries (Section 13) for installing batteries.
Page 8 In both cases the monitor The monitor will prepare for The monitor will then will automatically perform a testing for a few seconds. prompt you to insert a test self test where all segments strip, or to confirm the strip will appear on the display.
Page 9: Changing The Monitor Settings
If you are using the external power supply, the monitor will stay on indefinitely. NOTE: Turning the monitor OFF manually when it is not being used will help conserve battery power. If you are using battery power, and the monitor is left idle for about 10 minutes, the monitor will count down for about 10 seconds and then turn OFF.
Page 10 3. Select the desired format for displaying the date Choose between MM/DD/YY or DD/MM/YY formats. The first 2 sets of digits (DD/MM or MM/DD) will be flashing on the display. Use the and buttons to switch between date formats. Press button when you have the correct date format on the display.
Page 11 Press the 8. Change the hour 9. Change the minutes button when you have the correct minutes The hour will be flashing on The minutes will be flashing on the display. the display. Use the and on the display. Use the buttons to change the hour.
Page 12 Press the button when you have the correct display mode on the display. 11. Select the target range mode An INR target range may be set in your monitor to alert you when your test results fall outside the range. CAUTION: Always contact your health care provider before setting an INR target range that’s appropriate for you.
Page 13 13. Set the higher limit of the target range The higher limit of the target range will be flashing, and the High Target symbol ( ) will appear on the display. The “HI” message will also appear on your test result display whenever your result falls above the higher limit.
Page 14: Performing A Test
NOTES: • If you need to go back and correct any selections before you exit, you will need to repeat all Setup steps. Press the Setup button to return to the monitor display where you are prompted to insert a test strip. Press the Setup button again to re-enter Setup mode where you will begin by setting the date. • After you complete all Setup steps, you will return to the monitor display where you first entered Setup mode.
Page 15 2. Insert a test strip into the test strip guide on the monitor Remove a fresh test strip from its foil pouch. Insert it into the test strip guide so that the clear end with the vertical contact bars goes in first. On the blue end of the strip you should be able to read the word “INRatio®”...
Page 16 CAUTION: Always match the code on the monitor display with the strip code on the test strip pouch/container. Failure to do so may cause inaccurate results. NOTE: If you entered an invalid strip code, the CAUTION symbol ( ) will flash underneath the code. Re-enter the correct code beginning with the first digit, which is now flashing.
Page 17 What causes unexpected results: 1. A hematocrit (percentage of your blood that is red blood cells) that is higher or lower than the validated operating range of the INRatio2 system can cause an inaccurate result. Refer to the test strip package insert for more information. Verification of your hematocrit with your health care provider will help ensure the reliability of results obtained with the PT monitor.
Page 18 4. Liver diseases, congestive heart failure, thyroid dysfunction, and other diseases or conditions can affect the action of oral anticoagulants and the INR value. 5. Changes in diet, lifestyle, or taking nutritional supplements such as ginkgo biloba can affect the action of oral anticoagulants and the INR value. Be sure your health care provider is aware of any of these conditions before you begin testing, and any time there is change in health status or medications after you have begun testing.
Page 19: Collecting A Fingerstick Sample
9. Collecting a Fingerstick Sample Follow these steps to obtain a drop of blood from your finger. CAUTION: It is important that you use the correct technique and a 21 gauge lancet to obtain the right type and amount of blood sample. Failure to do so may cause inaccurate results.
Page 20: Reviewing Past Results In The Monitor Memory
6. Apply pressure to your fingertip Apply gentle, continuous pressure until a large, hanging drop of blood (at least 15 µL) forms. Apply the hanging drop of blood to the sample well on the test strip See Performing a Test (Section 8) for complete instructions. 7.
Page 21: Clearing Memory
When you enter Memory mode, your most recent result will appear on the display. Use the button to scroll to your previous result. (Example test result in memory — INR mode) Use the and buttons to scroll forward and backward through your previous results.
Page 22: Quality Control
Repeat the test if you believe the strips are okay. If you continue to get a “LO” or “HI” QC message, make note of the information on the monitor display and call HemoSense Technical Support for assistance. Monitor Display...
Page 23: Care And Cleaning Of Your Monitor
12. Care and Cleaning of your Monitor Follow these steps to keep your monitor clean. NOTE: No maintenance is required other than routine cleaning. Clean the outside of the monitor with a clean damp cloth. If necessary, a mild detergent or disinfectant (such as a 5% bleach solution or 70% isopropyl alcohol) may be used. Clean the area around the test strip guide with a swab or pad that has been dampened with alcohol or 5% bleach solution.
Page 24: Troubleshooting Error Messages
4. Replace the battery door NOTE: • Turning the monitor OFF manually when it is not being used will help conserve battery power. • Your settings for date, time, display mode, and target range will be saved as long as you replace the batteries within about five hours of the Low Battery symbol first appearing on the display. 14. Troubleshooting Error Messages Follow these steps to resolve most problems that you might encounter. Display Screen What it Means Action to Take...
Page 25 Display Screen What it Means Action to Take Ambient temperature is too Move the monitor to a cooler hot (above the operating location and try again in a few minutes. range) for the monitor to work properly. The monitor, strips and/or Make sure the monitor and ambient temperature is too strips are within the...
Page 26 The QC1 test result is below Repeat the test with a fresh the control range of the test strip. If this message monitor. continues, call HemoSense Technical Support for assistance. Repeat the test with a fresh The QC1 test result is above the control range of the test strip.
Page 27: Hazards, Lcd Display Icons, And Symbols
User Guide, the RF energy may interfere with other devices in the area. Call HemoSense Technical Support if you have any questions on RF interference. Any devices connected to the data port must be certified according to the respective IEC standards (i.e.
Page 28 Amendment 2, Sub-clause 6.8.2 a (EMC): This equipment has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2001. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.
Page 29 Temperature Caution Memory Batteries Replace are low Batteries Quality Control Quality Control Target Range Target Range Target Range Feature “On” Feature “Off” Symbols INRatio2 Monitor Lancet Device Batteries User’s Guide Quick Reference Sterile Blood Carrying Case Training Video Guide Lancets...
Page 30: Performance Characteristics And Specifications
Limited One Year Warranty Use of the INRatio2 PT Monitoring system The INRatio2 PT monitoring system (the “Monitor”) is designed for use in monitoring patients on oral anticoagulant therapy. Proper adherence to the instructions in the User Guide and package insert are critical to proper operation. WARNING: Failure to comply with the User Guide could lead to inaccurate results and resultant incorrect medication dosing which could result in injury or death.
Page 31: Glossary Of Terms
“Return Material Authorization” number and return instructions from HemoSense Technical Support by calling 1-877-436-6444. HEMOSENSE’S ENTIRE LIABILITY IN CONNECTION WITH THE MONITOR, REGARDLESS OF THE LEGAL OR EQUITABLE BASIS OF ANY CLAIM, IS LIMITED TO THE PURCHASE PRICE OF THE MONITOR. IN NO EVENT WILL HEMOSENSE BE LIABLE FOR ANY INCIDENTAL, INDIRECT,...
Page 32 The INRatio2 PT monitor measures the change in Reagent: A substance in the test strip that impedance in the blood sample to calculate Prothrombin Time (PT).
Page 33: Index
19. Index (listed alphabetically) Batteries Strip code Capillary blood sample 4, 8 Supplies Change monitor setup Symbols Choosing the units to be displayed Target range Classification Test strip guide Cleaning Test strip, diagram Customer service information 5, 35 Therapeutic range Date Time Error messages...
Page 34 Fax: 1 (408) 719-1184 Email: moreinfo@hemosense.com Web: www.hemosense.com Customer Service and Technical Support 1-877-436-6444 (toll-free) Customer Service available 7am – 5pm (PST), Monday – Friday Technical service available 24 hours/day, 7 days/week) © 2008 HemoSense Inc. All rights reserved. PN 0200427 Rev B...
Page 35: Customer Service And Technical Support
Fax: 1 (408) 719-1184 Email: moreinfo@hemosense.com Web: www.hemosense.com Customer Service and Technical Support 1-877-436-6444 (toll-free) Customer Service available 7am – 5pm (PST), Monday – Friday Technical service available 24 hours/day, 7 days/week) © 2008 HemoSense Inc. All rights reserved. PN 0200427 Rev B...